Welcome to my LinkedIn profile! Open to connect to opportunities within QA/RA departments within the Medical Device Industry! Certified QMS Lead Auditor with 10+ years in the Medical Device and Pharmaceutical industries, specialising in ISO 13485, MDSAP, EU MDR, and 21 CFR Part 820 compliance. Proven success in driving 90% QMS efficiency, 98% audit pass rate, and reducing non-conformances by 20%. Expert in CAPA, risk management (ISO 14971), supplier audits, and regulatory documentation. Adept in e-QMS tools (TrackWise, PMsmart) and cross-functional team collaboration to deliver quality excellence and regulatory readiness. 👉Contact me: selva2673@gmail.com +91 8122590434 Thank You 🙏